NCT06172257

A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)

A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects With Diabetic Macular Edema

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 401 (actual)
• Sponsor: Oculis · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of OCS 01 as compared to Vehicle in participants with Diabetic Macular Edema (DME).

Detailed description

A Phase 3 Pivotal Double-masked, Randomized, Vehicle-controlled, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in participants with Diabetic Macular Edema

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Dexamethasone ophthalmic suspension (OCS-01)	Participants will be dosed with one eye drop of OCS-01 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).
DRUG	Vehicle	Participants will be dosed with one eye drop of vehicle 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).

Timeline

• Start date: 2024-03-15
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2023-12-15
• Last updated: 2026-01-13

Locations

62 sites across 4 countries: United States, Argentina, India, Puerto Rico

Regulatory

• FDA-regulated drug study